Seminars in Oncology Nursing
Volume 26, Issue 1 , Pages 68-78 , February 2010

Health Related Quality of Life in NCI-Sponsored Cancer Treatment Trials

  • Ann M. O'Mara

      Affiliations

    • Corresponding Author InformationAddress correspondence to Ann M. O'Mara, PhD, RN, Palliative Care Research, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd., EPN 2010, Bethesda, MD 20892.
  • ,
  • Andrea M. Denicoff

References 

  1. O'Mara A, Denicoff AM, Reeve BB, et al. A Comparison of Patient-Reported Outcomes (PROs) in National Cancer Institute-Sponsored Treatment Trials in Breast, Colorectal, Lung, and Prostate Cancer During Two Time Periods: 1999-2003 and 2003-2008. [abstr] Proc Am Soc Clin Oncol. 2009;28(suppl):6618
  2. Shapiro AM, Benedict RHB, Schretlen D, et al. Construct and concurrent validity of the Hopkins Verbal Learning Test–revised. Clin Neuropsychol. 1999;13:348–358
  3. Schag CA, Heinrich RL. Development of a comprehensive quality of life measurement tool: CARES. Oncology (Huntingt). 1990;4:135–138
  4. Center for Epidemiologic Studies . National Institute of Mental Health. Center for Epidemiologic Studies Depression Scale (CES-D). Rockville, MD: National Institute of Mental Health; 1971;
  5. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–376
  6. EuroQol–a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208
  7. Wei JT, Dunn RL, Litwin MS, et al. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000;56:899–905
  8. Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy (FACT) scale: development and validation of the general measure. J Clin Oncol. 1993;1:570–579
  9. Schipper H, Clinch J, McMurray A, et al. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer (FLIC): development and validation. J Clin Oncol. 1984;2:472–483
  10. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–370
  11. Bernhard J, Hürny C, Coates AS, et al. for the International Breast Cancer Study Group (IBCSG) Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach. Ann Oncol. 1997;8:825–835
  12. Barry MJ, Fowler FJ, O'Leary MP, et al. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992;148:1549–1557
  13. Veit CT, Ware JE. The structure of psychological distress and well-being in general populations. J Consult Clin Psychol. 1983;51:730–742
  14. McNair DM, Lorr M, Droppleman LF. Manual for the profile of Mood States. Toronto, ON: Multi-Health Systems Inc.; 1992;
  15. De Haes JCJM, van Knippenberg FCE, Neijt JP. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer. 1990;62:1034–1038
  16. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483
  17. Waterhouse J, Metcalfe MC. Development of the sexual adjustment questionnaire. Oncol Nurs Forum. 1986;13:53–59
  18. McCorkle R, Young K. Development of a symptom distress scale. Cancer Nurs. 1978;1:373–378
  19. Litwin MS, Hays RD, Fink A, et al. Quality-of-life outcomes in men treated for localized prostate cancer. JAMA. 1995;273:129–135
  20. Ganz PA, Figlin RA, Haskell CM, et al. Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer. Does chemotherapy make a difference?. Cancer. 1989;63:1271–1278
  21. O'Connell MJ. A phase III trial of 5-fluorouracil and leucovorin in the treatment of advanced colorectal cancer. A Mayo Clinic/North Central Cancer Treatment Group study. Cancer. 1989;63(suppl 6):1026–1030
  22. Lindley C. Outcome assessment: functional status measures and quality of life as therapeutic endpoints in oncology. Top Hosp Pharm Manage. 1990;10:54–63
  23. Aaronson NK. Quality of life research in cancer clinical trials: a need for common rules and language. Oncology (Williston Park). 1990;4:59–70
  24. Cella DF, Tulsky DS. Measuring quality of life today: methodological aspects. Oncology (Williston Park). 1990;4:29–38discussion 69
  25. Nayfield SG, Ganz PA, Moinpour CM, et al. Report from a National Cancer Institute (USA) workshop on quality of life assessment in cancer clinical trials. Qual Life Res. 1992;1:203–210
  26. Moinpour CM, Provenzale D. Treatment for colorectal cancer: impact on health-related quality of life. In:  Lipscomb J,  Gotay CC,  Snyder C editor. Outcomes Assessment in Cancer. Cambridge, UK: Cambridge University Press; 2005;p. 178–200
  27. American Cancer Society. CancerFacts and Figures 2009. Breast. Available at: http://www.cancer.org/downloads/STT/500809web.pdf. (Accessed July 30, 2009).
  28. Ganz PA, Goodwin PJ. Quality of life in breast cancer - what have we learned and where do we go from here?. In:  Lipscomb J,  Gotay CC,  Snyder C editor. Outcomes Assessment in Cancer. Cambridge, UK: Cambridge University Press; 2005;p. 93–125
  29. Fairclough DL, Fetting JH, Cella D, et al. Quality of life and quality-adjusted survival for breast cancer patients receiving adjuvant therapy. Qual Life Res. 1999;8:723–731
  30. Peppercorn J, Herndon J, Kornblith AB, et al. Quality of life among patients with stage II and III breast carcinoma randomized to receive high-dose chemotherapy with autologous bone marrow support or intermediate-dose chemotherapy: results from Cancer and Leukemia Group B 9066. Cancer. 2005;104:1580–1589
  31. Land SR, Kopec JA, Yothers G, et al. Health-related quality of life in axillary node-negative, estrogen receptor-negative breast cancer patients undergoing AC versus CMF chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel Project B-23. Breast Cancer Res Treat. 2004;86:153–164
  32. Swain SM, Land SR, Ritter MW, et al. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat. 2009;113:315–320
  33. Paskett E, Herndon J, Donohue K, et al. Health-related quality of life in long-term breast cancer survivors: differences by adjuvant chemotherapy dose in Cancer and Leukemia Group B study 8541. Cancer. 2009;115:1109–1120
  34. Winer EP, Berry DA, Woolf S, et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol. 2004;22:2061–2068
  35. Zhou X, Segreti A, Cella D, et al. Lapatinib plus capecitabine versus capecitabine alone for HER2+ metastatic breast cancer: quality of life assessment. Breast Cancer Res Treat. 2009;117:577–589
  36. AmericanCancer Society. Facts and Figures, 2009. Prostate. Available at: http://www.cancer.org/downloads/STT/500809web.pdf. (Accessed July 30, 2009).
  37. Litwin DS, Talcott JA. Measuring quality of life in prostate cancer: progress and challenge. In:  Lipscomb J,  Gotay CC,  Snyder C editor. Outcomes Assessment in Cancer. Cambridge, UK: Cambridge University Press; 2005;p. 126–159
  38. Watkins-Bruner D, Scott C, Lawton C, et al. RTOG's first quality of life study—RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer. Int J Radiat Oncol Biol Phys. 1995;33:901–906
  39. Feigenberg SJ, Lee WR, Desilvio ML, et al. Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05. Int J Radiat Oncol Biol Phys. 2005;62:956–964
  40. Talcott JA, Manola J, Clark JA, et al. Time course and predictors of symptoms after primary prostate cancer therapy. J Clin Oncol. 2003;21:3979–3986
  41. Kornblith AB, Herndon JE, Zuckerman E, et al. The impact of docetaxel, estramustine, and low dose hydrocortisone on the quality of life of men with hormone refractory prostate cancer and their partners: a feasibility study. Ann Oncol. 2001;12:633–641
  42. Ahles TA, Herndon JE, Small EJ, et al. Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480. Cancer. 2004;101:2202–2208
  43. AmericanCancer Society. Facts and Figures, 2009. Colon and Rectum., Available at: http://www.cancer.org/downloads/STT/500809web.pdf. (Accessed July 23, 2009).
  44. NationalCancer Institute. Cancer Advances in Focus: Colorectal Cancer. Available at: http://www.cancer.gov/cancertopics/cancer-advances-in-focus/colorectal. (Accessed July 23, 2009).
  45. Kabbinavar FF, Wallace JF, Holmgren E, et al. Health-related quality of life impact of bevacizumab when combined with irinotecan, 5-fluorouracil, and leucovorin or 5-fluorouracil and leucovorin for metastatic colorectal cancer. Oncologist. 2008;13:1021–1029
  46. Meyerhardt JA, Sloan JA, Sargent DJ, et al. Associations between plasma insulin-like growth factor proteins and C-peptide and quality of life in patients with metastatic colorectal cancer. Cancer Epidemiol Biomarkers Prev. 2005;14:1402–1410
  47. Land SR, Kopec JA, Cecchini RS, et al. Neurotoxicity from oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: NSABP C-07. J Clin Oncol. 2007;25:2205–2211
  48. Kopec JA, Yothers G, Ganz PA, et al. Quality of life in operable colon cancer patients receiving oral compared with intravenous chemotherapy: results from National Surgical Adjuvant Breast and Bowel Project Trial C-06. J Clin Oncol. 2007;25:424–430
  49. AmericanCancer Society. Facts and Figures, 2009. Lung and Bronchus. Available at: http://www.cancer.org/downloads/STT/500809web.pdf. (Accessed July 23, 2009).
  50. Earle CC, Weeks JC. The science of quality of life measurement in lung cancer. In:  Lipscomb J,  Gotay CC,  Snyder C editor. Outcomes Assessment in Cancer. Cambridge, UK: Cambridge University Press; 2005;p. 160–177
  51. Schiller JH, Adak S, Cella D, et al. Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593–a phase III trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2001;19:2114–2122
  52. Moinpour CM, Lyons B, Grevstad PK, et al. Quality of life in advanced non-small-cell lung cancer: results of a Southwest Oncology Group randomized trial. Qual Life Res. 2002;11:115–126
  53. Naughton MJ, Herndon JE, Shumaker SA, et al. The health-related quality of life and survival of small-cell lung cancer patients: results of a companion study to CALGB 9033. Qual Life Res. 2002;11:235–248
  54. Siddiqui F, Kohl R, Swann S, et al. Gender differences in pretreatment quality of life in a prospective lung cancer trial. J Support Oncol. 2008;6:33–39
  55. Euroqol.org. What is EQ-5D? Available at: http://www.euroqol.org/eq-5d/what-is-eq-5d.html. (Accessed July 26, 2009).
  56. Ganz PA, Gotay CC. Use of patient-reported outcomes in phase III cancer treatment trials: lessons learned and future directions. J Clin Oncol. 2007;25:5063–5069

PII: S0749-2081(09)00116-8

doi: 10.1016/j.soncn.2009.11.009

Seminars in Oncology Nursing
Volume 26, Issue 1 , Pages 68-78 , February 2010